WO2023003021A1 - Systèmes et procédés d'échantillonnage en temps réel - Google Patents

Systèmes et procédés d'échantillonnage en temps réel Download PDF

Info

Publication number
WO2023003021A1
WO2023003021A1 PCT/JP2022/028229 JP2022028229W WO2023003021A1 WO 2023003021 A1 WO2023003021 A1 WO 2023003021A1 JP 2022028229 W JP2022028229 W JP 2022028229W WO 2023003021 A1 WO2023003021 A1 WO 2023003021A1
Authority
WO
WIPO (PCT)
Prior art keywords
guidewire
lumen
lumen catheter
dual lumen
catheter
Prior art date
Application number
PCT/JP2022/028229
Other languages
English (en)
Inventor
Madeline C. Graham
Jason T. Panzenbeck
Original Assignee
Olympus Medical Systems Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Olympus Medical Systems Corporation filed Critical Olympus Medical Systems Corporation
Publication of WO2023003021A1 publication Critical patent/WO2023003021A1/fr

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00147—Holding or positioning arrangements
    • A61B1/00148—Holding or positioning arrangements using anchoring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00147—Holding or positioning arrangements
    • A61B1/00154—Holding or positioning arrangements using guiding arrangements for insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/0051—Flexible endoscopes with controlled bending of insertion part
    • A61B1/0052—Constructional details of control elements, e.g. handles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/005—Flexible endoscopes
    • A61B1/01—Guiding arrangements therefore
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/0125—Endoscope within endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/267—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the respiratory tract, e.g. laryngoscopes, bronchoscopes
    • A61B1/2676—Bronchoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/4461—Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/46—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
    • A61B8/461—Displaying means of special interest
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/56—Details of data transmission or power supply
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A61B2010/045—Needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/12—Arrangements for detecting or locating foreign bodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/48—Diagnostic techniques
    • A61B6/486—Diagnostic techniques involving generating temporal series of image data
    • A61B6/487—Diagnostic techniques involving generating temporal series of image data involving fluoroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4272—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4416—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09125—Device for locking a guide wire in a fixed position with respect to the catheter or the human body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1047—Balloon catheters with special features or adapted for special applications having centering means, e.g. balloons having an appropriate shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires

Definitions

  • the present disclosure relates to systems and methods for real-time sampling.
  • Disclosed embodiments include apparatuses, systems, and methods for controlling the sampling of tissue using a guidewire.
  • the inventors have discovered, among other things, that use of a guide wire and sampling system with a guide wire guide can be used to obtain tissue samples from much deeper into the lungs.
  • the invention can be used within the working channel of devices, such as a robotic catheter due to the reduced size requirements through use of a guide wire and guide wire guide.
  • an apparatus in an illustrative embodiment, includes a handle, a flexible dual lumen catheter couplable to the handle, and a guidewire guide disposed at a distal end of the flexible dual lumen catheter.
  • a system in another illustrative embodiment, includes an imaging system, a guidewire system, and a real-time sampling system.
  • the imaging system includes a radial ultrasound probe.
  • the guidewire system includes a guidewire and a scope having a single working channel.
  • the real-time sampling system includes a handle, a flexible dual lumen catheter couplable to the handle, and a guidewire guide disposed at a distal end of the flexible dual lumen catheter, wherein the guidewire guide is configured to slidably receive the guidewire.
  • a method in still another illustrative embodiment, includes providing a dual lumen catheter and providing a guidewire guide disposed at least near a distal end of the dual lumen catheter.
  • a method visually detects target tissue, such as a lesion, a tumor, or the like, using an imaging device deployed from a single working channel endoscope.
  • the imaging device is removed, and a guidewire is delivered through the single working channel endoscope and anchored adjacent the target tissue.
  • the single working channel endoscope or an ultra-thin bronchoscope has a smaller outer diameter than a traditional multi-lumen endoscope or bronchoscope, thus allowing for travel to deeper and smaller air passageways.
  • the single working channel endoscope is then removed leaving only the guidewire.
  • a guidewire guide located on a dual-lumen or real-time sampling catheter is passed over a proximal end of the anchored guidewire, then advanced until adjacent the target tissue.
  • a radial ultrasound probe is inserted into a lumen of the dual lumen catheter, then the target tissue is reacquired with the radial ultrasound probe.
  • a tissue sampling tool is advanced through the other lumen of the dual lumen catheter, out a distal port of the dual lumen catheter, and into the target tissue. Then, the tissue sampling tool and the sampled tissue are removed for analysis.
  • FIGURE 1 is a perspective view and block diagram of an illustrative bronchoscope system.
  • FIGURE 2 is a side view and block diagram of a real-time sampling system;
  • FIGURE 3 is a perspective view of a portion of the bronchoscope with imaging components within an airway performing a first function.
  • FIGURE 4 is a side view of an illustrative guidewire.
  • FIGURE 5 is a perspective view of a portion of the bronchoscope and the guidewire of FIGURE 4 within the airway performing a second function.
  • FIGURE 6 is a side, x-ray view of a distal end of the real-time sampling system of FIGURE 2.
  • FIGURE 7 is a side view of the real-time sampling system of FIGURE 2 in a tissue sampling operation.
  • FIGURE 8 is a side view of the real-time sampling system of FIGURE 2 in a tissue sampling operation.
  • FIGURE 9 is a flow diagram of an illustrative method for performing tissue sampling.
  • a bronchoscope system 20 includes a bronchoscope 22 with an insertion tube 26, and image processor 30, and a display device 32.
  • the bronchoscope 22 includes a camera that provides image data to the image processor 30 for generation of an image for presentation on the display device 32.
  • a radial ultrasound probe 28 is slidably received within the bronchoscope 22 via a port 24 of a handle 25. The radial ultrasound probe 28 also maybe in data communication with the image processor 30.
  • the display device 32 is in wired or wireless signal communication with the image processor 30.
  • the display device 32 presents images based on information received from the camera of the bronchoscope 22 and/or a radial ultrasound transducer at the distal end of the radial ultrasound probe 28.
  • a diagnostic bronchoscope e.g., BF-MP190F produced by Olympus(R)
  • EBUS radial endobronchial ultrasound
  • the bronchoscope 22 may include a 3.0 mm distal-end outer diameter with a 1.7 mm working channel, thereby facilitating deep access into the lung.
  • Other types of endoscopes may be used such as an endoscope with an outer diameter less than 4.0 mm, less than 3.5 mm, less than 3.2 mm, less than 3.0 mm, and the like.
  • a guidewire (not shown) may be received within the handle 25 and the insertion tube 26 via the port 24.
  • the guidewire will be described in more detail below.
  • the EBUS could be adapted or replaced by a piezoelectric micromachined ultrasonic transducer (PMUT) or a capacitive micromachined ultrasonic transducer (CMUT).
  • PMUT piezoelectric micromachined ultrasonic transducer
  • CMUT capacitive micromachined ultrasonic transducer
  • the PMUT or CMUT based sensor allows for further miniaturization of the imaging device and enables use through even smaller catheter systems.
  • the PMUT or CMUT based sensor could be used via a robotic catheter system to locate target tissue. A guide wire could then be placed as discussed below, and a dual lumen catheter then guided through a working channel of the robotic catheter over the small guide wire to the target tissue for sampling.
  • the insertion tube 26 of the bronchoscope 22 is inserted into the location of a suspected tumor or lesion. Then, the radial ultrasound probe 28 is passed through the bronchoscope and out the distal end. The radial ultrasound probe 28 provides image data for processing by the image processor 30 and display on the display device 32. Once the displayed images show the presence of any target tissue, i.e., lesions, tumors, the radial ultrasound probe 28 is removed from the bronchoscope 22. While keeping the insertion tube 26 in place, the guidewire is passed through the working channel of the bronchoscope 22 to a distance within the lung slightly distal of where the target tissue was identified. The guidewire is anchored within the lung, then the bronchoscope 22 is removed leaving the guidewire within the lung.
  • a multi-lumen catheter device 40 includes a handle 41 and a flexible insertion tube 42.
  • the multi-lumen catheter device 40 may receive an imaging device 50, such as without limitation, a radial ultrasound probe, that is receivable within a first lumen of the multi-lumen catheter device 40.
  • the imaging device 50 is a PMUT or a CMUT based ultrasound probe.
  • the PMUT or CMUT based sensors can operate in a manner similar to the following discussion related to the radial ultrasound probe. Although, PMUT and/or CMUT based sensors are typically not designed to generate a 360-degree image as may be provided by the radial ultrasound probe.
  • a directional ultrasound probe such as a PMUT or CMUT, is useful in providing guidance to the sampling needle (which is dependent on properly radial orientation).
  • the imaging device 50 includes a radial ultrasound transducer that is in data communication with an image processor 52.
  • the image processor 52 is in data communication with a display device 54 for processing data received.
  • the display device 54 presents images in response to receiving the processed image data from the image processor 52.
  • a medical device 44 having a handle and a flexible active portion is receivable within a port 46 of the handle 41 which leads to a second lumen of the flexible insertion tube 42.
  • the distal end of the flexible insertion tube 42 includes an exit port for allowing the medical device 44 to exit the second lumen to procure a tissue sample at a desired location within a body.
  • the medical device 44 also may include a stylet (not shown in FIGURE 2) that may be removably insertable into and/or through the needle.
  • the medical device 44 may include biopsy forceps, cytology brushes, needles, or the like.
  • the flexible insertion tube 42 is fixedly secured to the handle 41 while the medical device 44 and the imaging device 50 are slidably received into the flexible insertion tube 42 via the handle 41.
  • the insertion tube 26 of the bronchoscope 22 is inserted into an airway 70 to a suspected location within the lung where target tissue 72 may be located or as deep into the lung as the insertion tube 26 will go.
  • a distal end 74 of the radial ultrasound probe 28 is passed through a working channel of the bronchoscope 22 and out a distal end of the insertion tube 26.
  • the distal end of the insertion tube 26 may include a camera 76 and illumination devices/lights and/or fiber optic wires.
  • the camera 76 delivers the image data to the display 32 via the image processor 30 provide live feedback to an operator.
  • the robotically steerable catheter and fiber optic imaging can be used to assist in the positioning of the distal end 74 of the ultrasound probe 28 near the target tissue 72.
  • the insertion tube 26 would be the working channel of a robotic catheter device.
  • a guidewire 58 includes an internal lumen 60 that extends from a proximal end to a distal port 62. Surrounding the distal end of the guidewire 58 is an anchoring mechanism, such as, without limitation, an inflatable balloon 64. The proximal end of the guidewire 58 is configured to attach to a gas or fluid supply device 78.
  • the gas or fluid supply device 78 may be a syringe, an air pump, or the like. Wires/tubes having a lumen with a balloon are well known in the art and no further explanation is necessary for a person of skill in the art to understand the disclosed subject matter.
  • the radial ultrasound probe 28 is removed from the working channel of the bronchoscope 22. Then, the guidewire 58 is inserted into the working channel of the bronchoscope 22 while maintaining the insertion tube 26 in the same position it was during use of the radial ultrasound probe 28. The guidewire 58 is extended beyond the distal end of the insertion tube 26 past a location where the target tissue 72 was identified.
  • the balloon 64 is inflated using the supply device 78. The inflated balloon 64 applies pressure to the walls of the airway 70, thus anchoring the guidewire 58 in place.
  • a distal end 80 of the flexible insertion tube 42 of the dual-lumen catheter 40 includes a first lumen 82 configured to receive the radial ultrasound probe 50 and a second lumen 84 configured to receive the medical device 44.
  • the second lumen 84 includes a ramp and an exit port at a distal end. The ramp is configured to deflect the medical device 44 as it exits the exit port.
  • the proximity of the exit port to the first lumen 82 allows the ultrasound probe 50 to provide an ultrasonic image of the medical device 44 as it exits the exit port. This potentially allows an operator to see the medical device 44 as it enters into target tissue.
  • the distal end 80 includes orientation pins 92 located on the same half of the distal end 80 as the ramp and exit port. Images produced by the radial ultrasound probe 50 received within the first lumen 82 produce images with feedback from the orientation pins 92 and the medical device 44. The feedback of the medical device 44 would appear within a short angle between the feedback of the orientation pins 92.
  • the orientation pins 92 provide guidance as to the position and orientation of the distal end 80 to ensure an understanding of where the medical device 44 will exit the exit port thereby assisting in obtaining a sample of the target tissue.
  • the guidewire tracking device 86 may be located on a side of the distal end 80 opposite from the exit port. This keeps the guidewire tracking device 86 from interfering with ultrasound images of the orientation pins 92 and the medical device 44.
  • the guidewire tracking device 86 may be a closed or open (helical) guide or loop device configured to slidably receive the guidewire 58.
  • the guidewire tracking device 86 may include a longitudinal axis that is approximately parallel to a longitudinal axis of the distal end of the insertion tube 42.
  • the guidewire tracking device 86 may be formed of a medical grade material having a compliant or non-compliant form.
  • the guidewire tracking device 86 may be frictionally attached with a heat shrink material, attached with a medical grade adhesive, molded simultaneously with the forming of the insertion tube 42, or the like.
  • the guidewire tracking device 86 may include a single loop or tube formed from a metal or plastic wire.
  • the bronchoscope 22 has been removed while the guidewire 58 remains anchored by the balloon 64 within the airway 70.
  • the insertion tube 42 of the real-time sampling device 40 has been advanced to a location near the target tissue 72 by virtue of the guidewire tracking device 86 receiving the guidewire 58. Fluoroscopy may be used to allow an operator to visually track the insertion tube 42 relative to the guidewire 58.
  • the radial ultrasound probe 50 is advanced to the distal end of the first lumen 82.
  • the medical device 44 is passed through the second lumen 84, out the exit port, and into the imaged target tissue 72.
  • the medical tool 44 may be repeatedly inserted into the target tissue 72. Once the operator has completed sampling of the target tissue 72, all the devices within the airway 70 are removed.
  • the ultrasound sensor When utilizing ultrasonic imaging, it is necessary to transmit the ultrasound waves through a proper medium, typically a fluid or gel in contact with the tissue to be imaged.
  • a proper medium typically a fluid or gel in contact with the tissue to be imaged.
  • the ultrasound sensor is placed in direct contact with the tissue to be imaged.
  • the anchor mechanism balloon assists in ensuring that the ultrasound probe (e.g., imaging device 50) within the distal end 80 is positioned against the tissue wall to ensure proper ultrasound transmission.
  • one method of assisting in positioning the distal end 80 is to offset the guide wire connection with the balloon to bias the position within the airway (lumen).
  • the position of the guide wire guide on the distal end 80 also plays a key role in biasing the imaging device 50 into a proper position against the tissue side wall.
  • FIGURE 8 illustrates an example of the imaging device 50 within the distal end 80 biased against the sidewall of an airway adjacent to the target tissue 72. Note, the portion of the distal end 80 containing the imaging device 50 is a suitable medium for passing ultrasonic waves for imaging purposes.
  • a process 100 for performing tissue sampling is provided.
  • a dual-lumen catheter with a guidewire guide attached at or near a distal end is provided.
  • target tissue is detected using an imaging device delivered via an ultra-thin endoscope.
  • a guidewire is delivered to a location near the detected target tissue and anchored in place.
  • the endoscope is removed leaving the guidewire in place.
  • the guidewire is inserted through a guidewire guide on a dual-lumen catheter.
  • the dual-lumen catheter is advanced to location near the target tissue by following the guidewire.
  • an imaging device is inserted into the dual-lumen catheter.
  • target tissue is detected with the inserted imaging device.
  • a tissue sampling tool is inserted into the dual-lumen catheter.
  • a sample of the target tissue is taken with the tissue sampling tool, then all the inserted components are removed.
  • An apparatus comprising: a handle; a flexible dual lumen catheter couplable to the handle; and a guidewire guide disposed at a distal end of the flexible dual lumen catheter.
  • the flexible dual lumen catheter includes: a first lumen configured to slidably receive an imaging device; and a second lumen configured to slidably receive a medical tool.
  • the guidewire guide includes a first longitudinal axis; a portion of the flexible dual lumen catheter adjacent to an attachment point with the guidewire guide includes a second longitudinal axis, and the first longitudinal axis and the second longitudinal axis are parallel.
  • a system comprising: an imaging system including: a radial ultrasound probe; a guidewire system including: a guidewire; and a scope comprising a single working channel; and a real-time sampling system including: a handle; a flexible dual lumen catheter couplable to the handle; and a guidewire guide disposed at a distal end of the flexible dual lumen catheter, wherein the guidewire guide is configured to slidably receive the guidewire.
  • the real-time sampling system further includes a medical tool
  • the flexible dual lumen catheter includes: a first lumen configured to slidably receive the radial ultrasound probe; and a second lumen configured to slidably receive the medical tool.
  • the handle includes: a first port and a first lumen configured to slidably receive the radial ultrasound probe; and a second port and a second lumen configured to slidably receive the medical tool.
  • the imaging system further includes: an image processor configured to: receive image data from the radial ultrasound probe; and generate images responsive to the received image data; and a display device being in data communication with the image processor being configured to generate a display responsive to the generated images.
  • the system of G-K wherein the scope includes: a handle including a port and a lumen configured to separately receive the radial ultrasound probe and the guidewire; and a flexible catheter couplable to the handle, the flexible catheter including a lumen and an outer diameter less than 3.2 mm.
  • the guidewire guide includes a first longitudinal axis; and a portion of the flexible dual lumen catheter adjacent to an attachment point with the guidewire guide includes a second longitudinal axis, the first longitudinal axis and the second longitudinal axis are parallel.
  • a method comprising: providing a dual lumen catheter; and providing a guidewire guide disposed at least near a distal end of the dual lumen catheter.
  • providing the guidewire guide includes: attaching the guidewire guide at least near the distal end of the dual lumen catheter, such that a first longitudinal axis of the guidewire guide is parallel to a second longitudinal axis of the dual lumen catheter.
  • N-O further comprising: visually detecting target tissue using an imaging device deployed from a single working channel endoscope.
  • the method of P further comprising: delivering a guidewire to a location within an airway near the detected target tissue via the single working channel endoscope, wherein the single working channel endoscope includes an insertion tube with an outer diameter less than 3.2 mm; anchoring the guidewire within the air passageway; removing the endoscope; passing the guidewire guide over a proximal end of the anchored guidewire; and advancing the dual lumen catheter within the airway adjacent to the detected target tissue responsive to the guidewire guide traversing over the anchored guidewire.
  • R The method of Q, further comprising: inserting a radial ultrasound probe within a lumen of the dual lumen catheter; imaging the target tissue with the radial ultrasound probe.
  • the method of R further comprising: advancing a tissue sampling tool through the other lumen of the dual lumen catheter, out a distal port of the dual lumen catheter, and into the imaged target tissue.
  • anchoring includes inflating a balloon at a distal end of the guidewire.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Public Health (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Physiology (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Endoscopes (AREA)

Abstract

L'invention concerne des appareils, des systèmes et des procédés de commande de l'échantillonnage de tissu à l'aide d'un fil-guide. Dans un mode de réalisation illustratif, un appareil comprend une poignée, un cathéter à double lumière flexible pouvant être couplé à la poignée, et un guide de fil-guide disposé au niveau d'une extrémité distale du cathéter à double lumière flexible.
PCT/JP2022/028229 2021-07-20 2022-07-20 Systèmes et procédés d'échantillonnage en temps réel WO2023003021A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163223743P 2021-07-20 2021-07-20
US63/223,743 2021-07-20

Publications (1)

Publication Number Publication Date
WO2023003021A1 true WO2023003021A1 (fr) 2023-01-26

Family

ID=84975727

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2022/028229 WO2023003021A1 (fr) 2021-07-20 2022-07-20 Systèmes et procédés d'échantillonnage en temps réel

Country Status (2)

Country Link
US (1) US20230025475A1 (fr)
WO (1) WO2023003021A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2615211A (en) * 2019-07-03 2023-08-02 Olympus Medical Systems Corp Real-time sampling device

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240206979A1 (en) * 2022-12-26 2024-06-27 SoundCath, Inc. Endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) bronchoscope

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006020944A (ja) * 2004-07-09 2006-01-26 Terumo Corp カテーテル
US20130317339A1 (en) * 2012-05-23 2013-11-28 Biosense Webster (Israel), Ltd. Endobronchial catheter
WO2015153931A1 (fr) * 2014-04-02 2015-10-08 The Board Of Trustees Of The Leland Stanford Jr. University Dispositifs de biopsie, systèmes et procédés d'utilisation
US20160302762A1 (en) * 2015-04-20 2016-10-20 Volcano Corporation Dual lumen diagnostic catheter

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2006020944A (ja) * 2004-07-09 2006-01-26 Terumo Corp カテーテル
US20130317339A1 (en) * 2012-05-23 2013-11-28 Biosense Webster (Israel), Ltd. Endobronchial catheter
WO2015153931A1 (fr) * 2014-04-02 2015-10-08 The Board Of Trustees Of The Leland Stanford Jr. University Dispositifs de biopsie, systèmes et procédés d'utilisation
US20160302762A1 (en) * 2015-04-20 2016-10-20 Volcano Corporation Dual lumen diagnostic catheter

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2615211A (en) * 2019-07-03 2023-08-02 Olympus Medical Systems Corp Real-time sampling device
GB2615211B (en) * 2019-07-03 2024-02-07 Olympus Medical Systems Corp Real-time sampling device

Also Published As

Publication number Publication date
US20230025475A1 (en) 2023-01-26

Similar Documents

Publication Publication Date Title
WO2023003021A1 (fr) Systèmes et procédés d'échantillonnage en temps réel
JP4767252B2 (ja) 肺のアクセス装置
US8135454B2 (en) Diagnosing and performing interventional procedures on tissue in vivo
US20130053694A1 (en) Blood vessel sensing catheter having working lumen for medical appliances
US8668654B1 (en) Cytological brushing system
US8876730B2 (en) Diagnostic or treatment tool for colonoscopy
US20090204005A1 (en) Puncture resistant catheter for sensing vessels and for creating passages in tissue
US9295455B2 (en) Biopsy system and biopsy method
US20180338673A1 (en) Surgical sheath and surgical apparatus including the same
WO2006109377A1 (fr) Appareil de traitement médical
US9241614B2 (en) Tools for use in esophagus
EP3277192B1 (fr) Dispositifs pour imagerie à ultrasons
US20220054763A1 (en) Variable pitch flexible needle
WO2016145259A1 (fr) Dispositifs et procédés d'analyse de tissus
US20170245841A1 (en) Systems and methods for improved tissue sampling
CN116261419A (zh) 用于三重成像混合探头的系统和方法
WO2016021269A1 (fr) Système de collecte de tissu
WO2013125475A1 (fr) Système de biopsie
JP4578824B2 (ja) ガイドワイヤ式カプセル内視鏡装置
CN219645761U (zh) 一种超声内窥镜及其头端部
JP2022126612A (ja) リアルタイムサンプリングデバイス
JP2002253479A (ja) 誘導システム

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22845954

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 22845954

Country of ref document: EP

Kind code of ref document: A1